Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of REGN475 in patients with pain due to thermal injury.

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Detailed Description

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Conditions

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Thermal Injury Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1

R475

Group Type EXPERIMENTAL

R475

Intervention Type DRUG

IV

Dose 2

R475

Group Type EXPERIMENTAL

R475

Intervention Type DRUG

IV

Dose 3

Placebo to match R475 dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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R475

IV

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males or females, ages 18 to 50, who have been hospitalized as a result of thermal injury
2. Moderate to severe procedural pain intensity (during wound care) on each of the initial assessment days

Exclusion Criteria

1. Patients with burns caused by chemical exposure or electricity
2. Patients with inhalation injury or with evidence of pneumonia, cellulitis, or infection
3. Patients with traumatic musculoskeletal injuries (eg, bone fractures or dislocations) or traumatic head or chest injuries
4. Significant pre-injury concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, psychiatric (including significant anxiety or depression), lymphatic disease, or drug dependence (alcohol or drug abuse), that would adversely affect the patient's management, recovery, or affect mortality or the patient's compliance with protocol assessments.
5. Women who are pregnant or nursing

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No